[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100219113":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":34,"locations":29,"responsibleParty":40,"collaborators":29,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":29,"eligibilityCriteria":48,"healthyVolunteers":44,"sex":49,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":29,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":63,"whyStopped":29,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":29},{"fullName":5,"class":6},"Bausch Health Americas, Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"bupropion hydrobromide","EXPERIMENTAL","study drug",[13],"Drug: bupropion hydrobromide",{"label":15,"type":16,"description":15,"interventionNames":17},"placebo","PLACEBO_COMPARATOR",[18],"Drug: Placebo",[20,25],{"type":21,"name":9,"description":11,"armGroupLabels":22,"otherNames":23},"DRUG",[9],[24],"Aplenzin",{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"Placebo","placebo arm",[15],null,[31],{"name":32,"affiliation":5,"role":33},"Varsha Bhatt","STUDY_DIRECTOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":29,"email":39},"Jessica Ferrigno","CONTACT","520-246-8205","jessica.ferrigno@bauschhealth.com",{"type":41,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100219113","phase-4-efficacy-and-safety-of-bupropion-hydrobromide-in-adolescents-and-children-with-major-depressive-disorder-100219113",false,"NCT02129751","Efficacy and Safety of Bupropion Hydrobromide in Adolescents and Children With Major Depressive Disorder","A Double-Blind, Placebo-Controlled, Multicenter Study of Efficacy and Safety of Bupropion Hydrobromide in Adolescents and Children With Major Depressive Disorder","Inclusion Criteria:\n\n* Male or female outpatients aged ≥7 to \\\u003C18 years (at Screening Visit 1).\n* Provide assent (subject) and written informed consent (parent\u002Flegal representative) and Health Insurance Portability and Accountability Act (HIPAA) for study participation (at Screening Visit 1).\n* Meet diagnostic criteria for MDD as defined in the DSM IV-TR5 at Screening Visits 1 and 1a (K-SADS-PL; see Appendix 17.2).\n* Current depressive episode of at least 4 weeks' duration as noted in the subject's history (Screening Visit 1).\n* Total CDRS-R raw score ≥45 at both the Screening and Baseline Visits (Visits 1 and 2) (see Appendix 17.3).\n* CGI-S score of ≥4 at the Baseline Visit (Visit 2) (see Appendix 17.4).\n\nExclusion Criteria:\n\n* are unable to swallow medications without difficulty\n* have known hypersensitivity to bupropion hydrobromide\n* are pregnant or planning to get pregnant or are lactating\n* Women of childbearing age unable to use at least one method of effective contraception for the duration of the study\n* Previous history of attempted suicide\n* are unable to understand and communicate effectively with parent, Investigator, and study coordinator\n* are at immediate risk of requiring hospitalization, in the Investigator's opinion\n* have current seizure disorder or history of seizures or head trauma\n* have history or presence of clinically significant medical conditions or clinically important laboratory abnormalities\n* have ECG or physical examination abnormality at screening\n* have body weight less than the 3rd percentile or greater than the 97th percentile for age.","ALL","7 Years","17 Years",{"count":53,"type":54},246,"ESTIMATED","INTERVENTIONAL",[57],"PHASE4","Double-Blind, Placebo-Controlled, Multicenter Study of Efficacy and Safety",[60],"Major Depressive Disorder",[62,9],"able to swallow medications without difficulty","NOT_YET_RECRUITING","2025-09-11",{"date":66,"type":67},"2025-09-17","ACTUAL",{"date":69,"type":54},"2026-06",{"date":71,"type":54},"2029-12",{"name":5,"class":6}]